BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU SYSTEM 7000

    MDR report key: 6300425 · Received January 31, 2017

    Report

    Report Number
    MW5067647
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    November 28, 2016
    Report Date
    January 27, 2017
    Manufacturer
    HILL-ROM
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM TRUMPF TABLE IN OPERATING ROOM NOTED TO HAVE OPERATIONAL ISSUE. DUE TO ISSUE WITH HAND CONTROL, A VISUAL OF THE TABLE FOUND BLOOD HAD FLOWED THROUGH THE BUILT IN X-RAY CASSETTE HOLDER AND CAKED INTO ELECTRICAL OUTLET (PLUG-IN FOR TABLE.) HILL-ROM REP PRESENTED, INSPECTED AND REPORTED TO COMPANY. VENDOR AWARE OF TRUMPF TABLE ISSUES AND ADVISED OPERATING ROOM STAFF THIS WAS A PROBLEM WITH THIS TABLE. OPERATING ROOM STAFF WERE ASKED TO WATCH HOW THEY USED THE TABLE, ENSURE NOTHING IS PLACED UNDER THE BEDS AND ENSURE BEDS ARE CLEANED PROPERLY. POOR TABLE DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73854 TRU SYSTEM 7000 TABLE, OPERATING ROOM JEA HILL-ROM 1723633

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention